The ANCA Vasculitis Questionnaire (AAV-PRO©)

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT02507024

Collaborator

University of Oxford (Other), University of South Florida (Other)

280

Enrollment

Locations

17.1

Actual Duration (Months)

140

Patients Per Site

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this project is to develop a disease specific patient reported outcome measure (PROM) for patients with AAV (the AAV-PRO). Investigators are developing and validating a questionnaire to assess quality of life in patients with ANCA-associated vasculitis (AAV). Patients with AAV have inflammation in the small blood vessels leading to involvement of a range of organs and can suffer from ongoing disease activity or treatment side effects. Quality of life can be measured by patient reported outcome measures (PROMs).

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss) (EGPA) Churg-Strauss Syndrome (CSS) Granulomatosis With Polyangiitis (Wegener's) (GPA) Wegener Granulomatosis (WG) Microscopic Polyangiitis (MPA) ANCA-Associated Vasculitis (AAV) Vasculitis	Other: Online questionnaire

Detailed Description

Patients with ANCA-associated vasculitis have inflammation in the small vessels that impact a range of organs and Investigators understand that patients may suffer ongoing disease activity, as well as side effects from the treatments. Assessing patients quality of life can be an important tool for conducting clinical trials for new treatments and medications.

Quality of life can be measured by questionnaires called "patient reported outcome measures" (PROM). What is a patient-reported outcome? Patient-reported outcomes, or PROs, are patients' feedback on what they are feeling or what they are able to do as participants are dealing with a chronic disease . Patient-reported outcomes are important because they provide doctors and researchers information about patients' quality of life. Questionnaires can be designed to measure specific PROs that are of specific importance to a disease and can provide much needed information on evaluating the effectiveness of health care. The aim of this survey is to develop a disease specific patient reported outcome measure, or PROM, for patients with AAV.

A small group of Investigators and Patient-Partners developed this survey for people with ANCA-associated vasculitis (the AAV-PRO). Investigators will invite patients with AAV to complete the questionnaire they have designed, called the AAV-PRO. By analysing how people fill in the questionnaire, Investigators will be able to find out how well the questions work, and whether they need to ask all of them.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

280 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

The ANCA Vasculitis Questionnaire (AAV-PRO©)

Actual Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Intervention The online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life.	Other: Online questionnaire

Arm

Intervention/Treatment

Intervention

The online questionnaire includes questions about how ANCA-associated vasculitis effects patients quality of life.

Other: Online questionnaire

Outcome Measures

Primary Outcome Measures

Completion of AAV-PRO questionnaire. [6 months]
Analysis of how people fill in the questionnaire to determine if these specific questions work, and whether we need to ask all of them.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Registered in the Vasculitis Patient-Powered Research Network (V-PPRN)
Patients greater than 18 years of age
Diagnosis of ANCA-associated vasculitis including: Eosinophilic Granulomatosis with Polyangiitis (also called Churg-Strauss Syndrome), Granulomatosis with Polyangiitis (also called Wegener's granulomatosis or GPA), Microscopic Polyangiitis (MPA)